Field of the Invention
The invention relates to improvements made to systems, which are isolated from the external environment, for transferring a certain content between a chamber and a container. The improvements apply regardless of the direction of the transfer. However, in practice, it is understood that, all other things being equal, the transfer always occurs in the same direction.
Description of the Related Art
More particularly in the biopharmaceutical field, different embodiments of systems for transferring, in isolation from the external environment, a certain content, in one direction or another, between a chamber and a partially flexible container that can be moved relative to the chamber, are known.
One of these systems is known under the trademark BIOSAFE®, this system not being exclusive of others. Systems of this type are also described in, in particular, documents FR-A-1346486, EP-A-0688020, FR-A-2782071, and WO00/36610.
The device that is the object of the document FR-A-2 787 190, which describes a sealed junction device comprising two chambers equipped, respectively, with an access opening equipped with a door working with a flange and locking means on their respective flanges; connecting means that make it possible to link the two chambers and to form a passage between them, without running the risk of introducing therein elements coming from the external environment; and a mechanism that makes it possible to detect when the seal between the two chambers and the external environment is no longer ensured, are also known from the state of the art.
Transfers, such as those that can be carried out by such systems, can be necessary in a number of technical fields, in particular, but not exclusively, the biopharmaceutical field. The invention pertains quite especially to this field, as to those that can be considered as similar in regard to the requirements imposed.
The content—to be transferred or that is already transferred—is not crucial in and of itself in regard to the invention apart from the fact that it is designed to be, and thus must be able to be, transferred. In the biopharmaceutical field, it can, for example, involve a sterile object such as a container, a container element such as a plug, or a syringe, but also elements for monitoring the environment, or even waste produced during production or treatment operations, waste that is to be transferred in order to eliminate it.
Transfers, such as those considered here, occur within the framework of more complex processes in which a certain content undergoes one or more operations before and/or after transfer. These operations consist of production, treatment, handling, use, measurement, monitoring, analysis, etc.
The chamber of the transfer system can be, for example, rigid, stationary, and of more or less large size and typically comprises:                A first wall, for example rigid, provided with a first opening, for example circular, and with a first connection interface, for example a flanged device;        A first door, for example in the shape of a disk, mounted to move and arranged to be in the closed state or in the open state where, respectively, it closes or opens the first opening;        First joining means, for example joined to the first connection interface;        First maneuvering means of the first door to move it from one state to the other, for example, in the form of an arm, lever or the like;        External actuating means, for example, in the form of one or more handles, for controlling the first maneuvering means.        
In the case of a production line, a chamber, comprising a wall equipped with the same number of openings, connection interfaces, doors, joining means, means for maneuvering the door, and just as many transfer systems, is provided.
The container of the transfer system can be partially flexible and movable, such as a pouch.
Such a container can typically comprise:                A second wall provided with a second opening like the first opening that, when the container is joined to the chamber, is in communication with the first opening, and a second connection interface, for example, an additional flanged device of the first connection interface;        A second door arranged to be in the closed state or in the open state, where it closes or opens respectively the second opening;        Second joining means capable of working with the first joining means so as to produce a stationary, detachable, and airtight joining of the container to the chamber;        Second means for maneuvering the second door to move it from one state to the other, functionally joined to the first door, so that the opening or the closing of the first door can result in, respectively, the opening or closing of the second door.        
In the case of the transfer of the container to the chamber, at the beginning, the container is filled with its content, is disjoined from the chamber, and the first door and second door are in the closed state.
The operator draws the container close to the chamber and joins them, making their interfaces and their respective joining means work together. The container is then mounted on the chamber and accessible to the operator. If necessary, these operations are fully or partially automated.
In this situation, the operator can activate the actuating means, for example, to make the handle or handles that are part of it pivot. Alternately, this operation is either fully or partially automated.
The actuation, regardless of the manner in which it is achieved, controls the first maneuvering means, which move the first door from its closed state to its open state. The movement of the first door concomitantly leads to that of the second door. Thus, the two doors are brought from the closed state to the open state.
In this situation, the container is in tight communication—isolated from the external environment—with the chamber via their two open openings.
The operator can then transfer the content of the container into the chamber via the two openings in an airtight manner—isolated from the external environment. Or, as above, this operation is fully or partially automated.
Once the container is thus transferred, the operator can activate the actuating means, thereby controlling the first maneuvering means, which move the first door from its open state to its closed state and concomitantly that move the second door from its open state to its closed state.
The operator can then disjoin the container from the chamber. Or, as above, this operation is fully or partially automated.
Instead of the transfer taking place in the direction from the container to the chamber, it can take place in the opposite direction, from the chamber to the container. The operations then carried out are derived from those described above.
As appropriate, the container may or may not be for single use and then discarded after being used.
Such a system provides satisfaction regarding the transfer per se. Nevertheless, in the case of certain applications, particularly in the biopharmaceutical field, within the framework of the process in which this transfer occurs, the fact that the transfer per se provides satisfaction is not sufficient.
Actually, it is important, first of all, to ensure the safety of the transfers, for example to avoid the consequences that could result from mixing batches of containers filled with contents, or from bad handling or from the transfer of a content that should not have been transferred for whatever reason. This safety requirement is made all the more difficult since, visually, the containers look alike and the transfers must be carried out at a certain rate.
It is also important that the traceability of the contents is ensured during most of their shelf lives: before and after transfer.
It is also important to avoid consequences that might result from the transfer, not of the content to be transferred, but of a duplicate of the latter.
It is also important, in the case of single-use containers, that the container that was used for a transfer cannot be used for a subsequent transfer.
An embodiment using a bar code that attempts to provide a solution to the problem by using a bar code is known. However, this embodiment is not satisfactory since it is too complex.
Furthermore, the system of radio identification, currently designated RFID (Radio Frequency IDentification), which comprises, on the one hand, a transponder or RFID tag, which can be in the form of a label that has a substrate or the like bearing an antenna and an electronic chip and, on the other hand, a transmitter-receiver or reader, which can activate the transponder located a short distance away, is known. Thus, the transponder can receive the radio requests transmitted by the transmitter-receiver and respond to them. RFID technology is used for identification, traceability, verification testing, tracking, electronic opening of doors, access control, and communication.
The document WO2008/069846 describes a plastic container and a preform having an encapsulated RFID insert. The document EP-A-1583048 describes a process for producing a container with an RFID element.
The documents EP-A-1887581 and EP-A-2012323 refer to the sterilization or the radiation of a pharmaceutical device that comprises an RFID label.
The document EP-A-1850289 explains the application of an RFID system for the “workflow” of blood transfusion centers.
The document US-A-2003/0072676 describes a pouch that is designed to contain a blood product provided with an RFID label.
The document EP-A-2 080 553 relates to a method and a system designed to locate and identify test tubes placed in a receiving fixture by using labels fixed to the outside wall of these test tubes and that have a bar code. More particularly, the method comprises a series of stages that consists in scanning the bar codes so as to record the corresponding identification data and to determine the position of each test tube in the receiving fixture; if necessary, to read the additional data recorded on the RFID chips provided behind the labels; and to correlate the identification data, the positioning data and the additional data of each test tube.
Other means capable of storing information and transmitting it, making its short-range reading possible, and then of storing it for a certain use, are also known. Such systems operate either by radio, by infrared, or else by hard-wire connection. Techniques known under the trademarks of, for example, Bluetooth®, Zigbee® . . . are known.
Consequently, in the pharmaceutical field, as in those fields that can be considered similar in regard to the imposed requirements, systems, which are isolated from the external environment, for transferring a certain content between a chamber and a container, in one direction or another, need to be improved in regard to securing transfers, to the traceability of the contents during most of their shelf lives: before and after transfer, in regard to consequences that could result from the transfer, not of the content to be transferred, but of a duplicate of the latter, and finally in regard to the effectiveness of single-use containers holding the contents to be transferred. These improvements need to be provided in a simple fashion, to operate automatically as much as possible, and by means of equipment that is as inexpensive as possible.